U.S. patent application number 13/989499 was filed with the patent office on 2013-09-19 for variable stiffness catheter, intraluminal treatment system, and method.
This patent application is currently assigned to Cook Medical Technologies LLC. The applicant listed for this patent is Therese J. O'Day. Invention is credited to Therese J. O'Day.
Application Number | 20130245551 13/989499 |
Document ID | / |
Family ID | 44759787 |
Filed Date | 2013-09-19 |
United States Patent
Application |
20130245551 |
Kind Code |
A1 |
O'Day; Therese J. |
September 19, 2013 |
Variable Stiffness Catheter, Intraluminal Treatment System, And
Method
Abstract
A variable stiffness catheter includes an elongate tubular body
having proximal and distal body ends and defining a lumen extending
longitudinally between a fluid inlet in the proximal body end and a
fluid outlet in the distal body end. The catheter includes a vacuum
responsive stiffener coupled with the elongate tubular body, which
may include a stiffening medium such as an open cell foam having an
expanded state and a vacuum collapsed state. The stiffening medium
can transition between the expanded state at which it is relatively
flexible and the vacuum collapsed state at which it is relatively
inflexible via withdrawing fluid from the vacuum responsive
stiffener by way of a vacuum device.
Inventors: |
O'Day; Therese J.;
(Bloomington, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
O'Day; Therese J. |
Bloomington |
IN |
US |
|
|
Assignee: |
Cook Medical Technologies
LLC
Bloomington
IN
|
Family ID: |
44759787 |
Appl. No.: |
13/989499 |
Filed: |
September 23, 2011 |
PCT Filed: |
September 23, 2011 |
PCT NO: |
PCT/US11/52859 |
371 Date: |
May 24, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61416805 |
Nov 24, 2010 |
|
|
|
Current U.S.
Class: |
604/95.04 |
Current CPC
Class: |
A61M 25/0102 20130101;
A61M 25/0053 20130101; A61M 25/04 20130101; A61M 2025/0063
20130101 |
Class at
Publication: |
604/95.04 |
International
Class: |
A61M 25/01 20060101
A61M025/01 |
Claims
1. A variable stiffness catheter comprising: an elongate tubular
body including proximal and distal body ends, and defining a lumen
extending longitudinally between a fluid inlet located in the
proximal body end and a fluid outlet located in the distal body
end; and a vacuum responsive stiffener coupled with the elongate
tubular body.
2. The catheter of claim 1 wherein the elongate tubular body
includes an inner tubular body, and wherein the vacuum responsive
stiffener includes an outer tubular body positioned about the inner
tubular body, and a stiffening medium disposed between the inner
and outer tubular bodies.
3. The catheter of claim 2 wherein a cavity extends between the
inner and outer tubular bodies, and the stiffening medium surrounds
the inner tubular body within the cavity.
4. The catheter of claim 3 wherein the stiffening medium includes a
porous medium having an expanded state and a vacuum collapsed
state.
5. The catheter of claim 4 wherein the stiffening medium includes
an open cell foam.
6. The catheter of claim 3 wherein the stiffening medium includes a
plurality of beads.
7. The catheter of claim 1 wherein the distal body end includes a
radiopaque tip, and wherein the fluid outlet is formed in the
radiopaque tip.
8. A method of performing an intraluminal procedure on a patient
comprising the steps of: advancing a catheter having an elongate
tubular body through a body lumen of a patient; stiffening the
catheter at least in part by withdrawing a fluid from a stiffener
coupled with the elongate tubular body; and fluidly connecting the
body lumen with a fluid reservoir located outside of the patient by
way of a longitudinally extending lumen within the elongate tubular
body.
9. The method of claim 8 further comprising the steps of conveying
a second fluid from the fluid reservoir to the body lumen by way of
the longitudinally extending lumen, and limiting displacing the
catheter during conveying the second fluid by way of the stiffening
step.
10. The method of claim 9 wherein the step of limiting further
includes limiting displacing the catheter in response to an exit
pressure of the second fluid from the catheter.
11. The method of claim 10 wherein the step of conveying further
includes conveying a contrast agent in the second fluid into the
body lumen.
12. The method of claim 8 wherein the step of stiffening further
includes withdrawing the fluid from a cavity between the elongate
tubular body and an outer tubular body of the stiffener such that a
stiffening medium within the cavity transitions from a relatively
flexible state to a relatively inflexible state.
13. The method of claim 12 wherein the step of stiffening further
includes collapsing an open cell foam comprising the stiffening
medium.
14. An intraluminal treatment system comprising: a catheter having
an elongate tubular body including proximal and distal body ends,
and defining a lumen extending longitudinally between a fluid inlet
located in the proximal body end and a fluid outlet located in the
distal body end; a vacuum responsive stiffener coupled with the
elongate tubular body; and a vacuum device connectable with the
vacuum responsive stiffener.
15. The intraluminal treatment system of claim 14 further
comprising a fluid reservoir in fluid communication with the
lumen.
16. The intraluminal treatment system of claim 15 wherein the fluid
reservoir contains a liquid contrast agent, and further comprising
a manifold fluidly connecting the fluid reservoir with the lumen
and fluidly connecting the vacuum device with the vacuum responsive
stiffener.
17. The intraluminal treatment system of claim 14 wherein the
elongate tubular body includes an inner tubular body, and wherein
the vacuum responsive stiffener further includes an outer tubular
body positioned about the inner tubular body, and a stiffening
medium between the inner and outer tubular bodies.
18. The intraluminal treatment system of claim 17 wherein the
stiffening medium includes a porous medium having a relatively
flexible expanded state and a relatively inflexible vacuum
collapsed state.
19. The intraluminal treatment system of claim 18 wherein the
porous medium is in the expanded state and includes an open cell
foam, and further comprising a liquid within the porous medium.
20. The intraluminal treatment system of claim 18 wherein the
vacuum device includes a syringe.
Description
[0001] This Application is a National Stage of PCT/US2011/052859,
filed Sep. 23, 2011, which claimed the benefit of the filing date
of U.S. Provisional Application Ser. No. 61/416,805, filed Nov. 24,
2010.
TECHNICAL FIELD
[0002] The present disclosure relates generally to catheters for
use in intraluminal procedures, and relates more particularly to
stiffening a catheter within a body lumen of a patient by
withdrawing a fluid from a stiffener coupled with an elongate
catheter body.
BACKGROUND
[0003] A wide variety of catheters and the like are used for
accessing different body lumens in patients, and are used in a
large number of different types of procedures. Infusion catheters
are well known and widely used for delivering treatment agents into
the vascular system or other parts of a patient's body for the
treatment of thrombi, tumors, and various other types of undesired
tissue or abnormalities. Catheters are also used for introducing
contrast agents or dyes, and in the placement of intraluminal
treatment devices such as filters and stents. Still other examples
of the wide applicability of catheters in medical technology
include providing an access pathway for embolization mechanisms,
angioplasty devices, and even cutting tools and cameras.
[0004] Various entry techniques and pathways may be used to access
treatment locations within a body lumen of a patient. Percutaneous
access to the cardiovascular system for peripheral intervention
techniques is one well known example, and typically involves
forming an access opening in a patient's skin, and then guiding a
catheter by way of a wire guide through the vasculature while
manipulating the wire guide and catheter from a location outside of
the patient's body. Once a target location is reached, the catheter
may be used in whole or in part to conduct the example procedures
mentioned above. Related, but somewhat varying techniques are used
to access other body lumens such as the bladder, biliary ducts,
etc. A clinician is typically unable to know precisely where a
catheter is presently located within a patient without some
external mechanism such as an imaging device which enables in vivo
visualization on a monitor or the like. Despite a high level of
skill among many clinicians, as well as the availability of
sophisticated catheter guiding and imaging techniques, properly
placing a catheter for delivery of a contrast agent, introduction
of a treatment device, or for that matter any other purpose, is
still often a tricky endeavor. Even once placed, it is common for
catheters or the like to be relatively difficult to maintain in
position within the patient.
SUMMARY OF THE DISCLOSURE
[0005] In one aspect, a variable stiffness catheter includes an
elongate tubular body having proximal and distal body ends, and
defining a lumen extending longitudinally between a fluid inlet
located in the proximal body end and a fluid outlet located in the
distal body end. The variable stiffness catheter further includes a
vacuum responsive stiffener coupled with the elongate tubular
body.
[0006] In another aspect, a method of performing an intraluminal
procedure on a patient includes advancing a catheter having an
elongate tubular body through a body lumen of a patient, and
stiffening the catheter at least in part by withdrawing a fluid
from a stiffener coupled with the elongate tubular body. The method
further includes fluidly connecting the body lumen with a fluid
reservoir located outside of the patient by way of a longitudinally
extending lumen within the elongate tubular body.
[0007] In still another aspect, an intraluminal treatment system
includes a catheter having an elongate tubular body with proximal
and distal body ends, and defining a lumen extending longitudinally
between a fluid inlet located in the proximal body end and a fluid
outlet located in the distal body end. The system further includes
a vacuum responsive stiffener coupled with the elongate tubular
body, and a vacuum device connectable with the vacuum responsive
stiffener.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a partially sectioned side diagrammatic view,
including a detailed enlargement, of a variable stiffness catheter
according to one embodiment;
[0009] FIG. 2 is a sectioned view taken along line 2-2 of FIG.
1;
[0010] FIG. 3 is a sectioned view similar to FIG. 2 showing the
catheter in a stiffened state;
[0011] FIG. 4 is a sectioned view similar to FIG. 2 of a variable
stiffness catheter according to another embodiment;
[0012] FIG. 5 is a side diagrammatic view of an intraluminal
treatment system at one stage of an intraluminal treatment
procedure, according to one embodiment; and
[0013] FIG. 6 is a side diagrammatic view of the intraluminal
treatment system of FIG. 5 at another stage of the intraluminal
treatment procedure.
DETAILED DESCRIPTION
[0014] Referring to FIG. 1, there is shown a variable stiffness
catheter 10 according to one embodiment. Catheter 10 may include an
elongate tubular body 12 having a proximal body end 14, and a
distal body end 16 having a distal tip 18. Distal tip 18 may
include a distally narrowing taper 8, and has a fluid outlet 24
formed therein. A fluid inlet 22 is located in proximal body end
14, and body 12 defines a lumen 20 extending longitudinally between
fluid inlet 22 and fluid outlet 24. In one embodiment, distal tip
18 may be formed from or impregnated with a radiopaque material 36.
Lumen 20 defines a longitudinal axis A of elongate tubular body 12
extending between proximal body end 14 and distal body end 18.
[0015] Catheter 10 may further include a vacuum responsive
stiffener 26 coupled with elongate tubular body 12. In one
embodiment, elongate tubular body 12 may include an inner tubular
body, and stiffener 26 may include an outer tubular body 28
positioned about and coaxial with inner tubular body 12. A cavity
32 may extend between inner tubular body 12 and outer tubular body
28, and may include a generally cylindrical cavity centered about
longitudinal axis A and extending from proximal body end 14 to
distal tip 18. In one practical implementation strategy, cavity 32
may be closed within distal body end 16 such as at an attachment
location of distal tip 18, a point shown approximately via arrow X.
Cavity 32 may fluidly connect with a port 34 formed in a manifold
27 coupled with or comprising a part of proximal body end 14. Fluid
inlet 22 may also be formed in manifold 27, such that separate and
independent fluid connections may be made to lumen 20 and to cavity
32 from a location outside of the patient, for purposes which will
be apparent from the following description.
[0016] A stiffening medium 30 may be disposed between inner tubular
body 12 and outer tubular body 28, and positioned within cavity 32
such that stiffening medium 30 surrounds inner tubular body 12
within cavity 32. In the embodiment shown, stiffening medium 30
extends within cavity 32 approximately between a first location
shown via arrow Y in catheter 10, and a second location shown via
arrow X. It will thus be understood that a portion of cavity 32 may
be filled or substantially filled with stiffening medium 30,
extending approximately between the arrows Y and X, whereas another
portion of cavity 30 may be free of, or substantially free of,
stiffening medium 30. According to such a construction, the portion
of cavity 32 extending approximately from arrow Y in a proximal
direction to port 34 may serve as a fluid lumen for supplying or
withdrawing a fluid respectively to or from stiffening medium 30 in
a manner further described herein. In other embodiments, stiffening
medium 30 might fill all of cavity 32.
[0017] Referring also now to FIG. 2, there is shown a sectioned
view taken along line 2-2 of FIG. 1. In one embodiment, stiffening
medium 30 may include a porous medium attached to at least one of
inner tubular body 12 and outer tubular body 28, and having each of
an expanded state and a vacuum collapsed state. In one practical
implementation strategy, stiffening medium 30 may include an open
cell foam such as a foamed polyurethane material. In an alternative
embodiment shown in FIG. 4, a variable stiffness catheter 110
includes an elongate tubular body 112 comprising an inner tubular
body and defining a longitudinally extending lumen 120, and
including a vacuum responsive stiffener 126 functionally similar to
stiffener 26 but having certain differences. In particular,
stiffener 126 may include a stiffening medium 130 within a cavity
132 extending between inner tubular body 112 and an outer tubular
body 128, but instead of a foam material as in catheter 10,
stiffening medium 130 may include a plurality of beads.
[0018] As mentioned above, stiffening medium 30 may include a
porous medium, and having a relatively flexible expanded state and
a relatively inflexible vacuum collapsed state. The expanded state
may include a rest state of stiffening medium 30, whereas the
vacuum collapsed state may include a biased state assumed by
stiffening medium 30 when a vacuum is applied to cavity 32.
Referring to FIG. 3 in comparison to FIG. 2, there is shown
catheter 10 as it might appear when stiffening medium 30 has been
partially or fully collapsed by withdrawing a fluid such as air or
saline from cavity 32. It may be noted that stiffening medium 30
has collapsed or squeezed inward in a radial direction about
longitudinal axis A such that outer tubular body 28 is slightly
shrunk radially about inner tubular body 12. Depending upon the
materials and construction selected for catheter 10, physical
deformation of outer tubular body 28 and/or inner tubular body 12
may or may not occur and may or may not be visible to the naked
eye. Normally open pores or cells 31 in stiffening medium 30 may
nevertheless be expected to shrink or close when fluid is withdrawn
from cavity 32 under vacuum. As a result of applying a vacuum to
cavity 32 and withdrawing fluid, stiffening medium 30 transitions
from its relatively flexible expanded state to its relatively
inflexible vacuum collapsed state, the significance of which will
be further apparent from the following description.
[0019] A similar phenomenon can be expected to occur using the
embodiment shown in FIG. 4, wherein withdrawal of fluid from cavity
132 can be expected to deform outer tubular body 128 radially
inwardly about inner tubular body 112, such that the beads, for
example glass or plastic beads, comprising stiffening medium 130
begin to provide structural reinforcement or increased structural
reinforcement between inner and outer tubular bodies 112 and 128
and thereby stiffen catheter 110.
[0020] As mentioned above, stiffening medium 30 may include an open
cell foam such as a foamed polyurethane. In one practical
implementation strategy, catheter 10 may be made by way of a
process which includes curing a liquid polyurethane material in
contact with inner tubular body 12. For instance, inner tubular
body 12 may be dipped in or sprayed with an activated polymerizing
polyurethane starting material containing, or to which is added, a
blowing or foaming agent, and then the resulting polyurethane
material allowed to cure. Inner tubular body 12 having the cured,
foamed polyurethane coating may then be slid into outer tubular
body 28 and the respective tubular bodies attached via any suitable
procedure to render an assembly of inner and outer tubular bodies
12 and 28 and stiffening medium 30. An end of cavity 32 which is to
comprise the closed distal end of cavity 32 near arrow X may then
be closed or sealed via a suitable sealing material, or for
instance by melting material of inner tubular body 12 to material
of outer tubular body 28, and distal tip 18 attached. Stiffening
medium 30 may optionally be mechanically or chemically attached to
inner tubular body 12 by way of the reaction and curing process
which forms stiffening medium 30, depending upon the materials or
physical surface properties such as roughness. Other strategies for
attaching stiffening medium 30 to one or both of inner tubular body
12 and outer tubular body 28 are contemplated herein, such as by
way of suitable adhesives. Each of inner and outer tubular bodies
12 and 28 may be formed from biocompatible materials conventionally
used in the extrusion of elongate tubular bodies for intraluminally
placeable catheters. Nylon materials, fluoropolymers and other
suitable materials are well known and widely used. Catheter 110 may
be made by a process in which the beads comprising stiffening
medium 130 are poured into cavity 132 or otherwise carried into
cavity 132 such as by way of a fluid. Manifold 27 may be coupled
with each of inner and outer tubular bodies 12 and 28, or in the
case of catheter 110 inner and outer tubular bodies 112 and 128, to
render the completed variable stiffness catheter.
INDUSTRIAL APPLICABILITY
[0021] Turning now to FIG. 5, there is shown an intraluminal
treatment system 50 at one stage in performing an intraluminal
treatment procedure on a patient. Intraluminal treatment system 50
is shown using catheter 10, having been passed by way of an
introducer sheath 54 into a body lumen V of a patient. Catheter 110
and other catheter embodiments contemplated herein might similarly
be used, and thus the present description should be understood to
generically describe an example use of catheters within the context
of the present disclosure. In the illustrated embodiment,
introducer sheath 54 has passed through an opening in the patient's
skin and provides access to a body lumen V such as a vein or
artery. Catheter 10 has been advanced through body lumen V through
one or more turns and/or junctions, and is positioned in proximity
to a treatment site T such as a thrombus or the like. A wire guide
60 is shown extending through catheter 10 as it might appear where
catheter 10 has been advanced in an over-the-wire manner to the
desired location within body lumen V. Wire guide 60 may extend
through lumen 20, but in other versions (not shown) might pass
through a relatively short wire guide lumen formed in or near
distal tip 18 for rapid exchange applications, or through a second
lumen extending all the way through body 12 in parallel with lumen
20.
[0022] In FIG. 5, a fitting 56 is shown coupled with manifold 27,
and provides one access passage 61 for wire guide 60 to lumen 20,
and another access passage 63 for fluidly connecting a vacuum
device 52 with cavity 32 by way of a valve 58. It will thus be
understood from FIG. 5 that wire guide 60 may pass through fluid
inlet 22 in manifold 27, whereas a fluid connection between vacuum
device 52 and cavity 32 may be established by way of port 34. In
FIG. 5, valve 58 is shown in an open position as it might appear
where vacuum device 52 is being used to withdraw a fluid F from
cavity 32 to adjust stiffening medium 30 within catheter 10 from
its relatively flexible state to its relatively inflexible state in
the manner described herein. While vacuum device 52 has been
depicted as withdrawing fluid while wire guide 60 is positioned
within catheter 10, this need not always be the case, and in some
instances might even be disfavored. In other words, wire guide 60
might be withdrawn from catheter 10 prior to commencing withdrawing
fluid from cavity 32 by way of vacuum device 52.
[0023] In the illustrated embodiment, vacuum device 52 is shown as
a conventional manually operable syringe, however, in other
embodiments a different type of device such as a motorized vacuum
device or pump might be used. It may also be noted that fluid F is
shown as a liquid. It may be desirable in some instances to
withdraw air from cavity 32 and thus stiffening mechanism 26, and
replace the air with a suitable liquid such as saline, prior to
advancing catheter 10 through the body lumen as shown. Substituting
a liquid F for the air normally residing in cavity 32 and
stiffening medium 30 might be performed by applying a vacuum to
port 34 with catheter 10 positioned outside of the patient, and
then injecting a liquid back into cavity 32, prior to commencing
advancing catheter 10 through the body lumen. In still other
embodiments, the fluid withdrawn from catheter 10 to stiffen the
same may simply be air and no substitution of a liquid needed.
[0024] Referring also now to FIG. 6, there is shown system 50 as it
might appear at another stage of an intraluminal treatment
procedure. In FIG. 6, a fluid reservoir 62 is positioned outside
the patient and contains another fluid G, and is shown connected
with fitting 56 as it might appear where in fluid communication
with lumen 20, and thus in fluid communication with body lumen V.
In one embodiment, fluid reservoir 62 may contain a liquid contrast
agent, a variety of which are well known and widely used. Valve 58
has been adjusted from an open position shown in FIG. 5 to a closed
position after withdrawing fluid F from catheter 10, such that
catheter 10 is in a relatively stiff state within body lumen V. An
imaging system 70 is shown positioned such that imaging by way of
radiography or the like of treatment location T may occur. Fluid G
is also shown exiting distal tip 18. Fluid reservoir 62 might be
equipped with a pressure cuff or the like, or an infusion pump
used, to enable injecting liquid G into body lumen V as
desired.
[0025] It has been discovered that an exit pressure of fluid from a
catheter tip within a body lumen, such as an exit pressure of a
liquid containing a contrast agent or the like, can cause the
associated catheter to be displaced within the body lumen. In other
words, when conveying a fluid from a fluid reservoir located
outside of a patient to a body lumen, a back pressure of the
exiting fluid on the catheter can cause the catheter to shift from
a desired location and/or orientation within the body lumen. One
mechanism specifically responsible for losing location is believed
to be a straightening of a curved catheter in response to shifting
back from a location just beyond a curve or junction. Since a
catheter may have some bias towards a straight shape, once a point
of contact with a patient's vasculature which is holding the
catheter curved is lost, the catheter may revert to being more or
less straight, ending up with the catheter tip out of place. In
some instances, the displacement of the catheter may be such that
injection of contrast agent or the like occurs into a portion of
the body lumen different from that which is targeted. Thus, where
imaging of a treatment site is desired a catheter injecting liquid
contrast agent can actually be displaced so that the contrast agent
does not enter the portion of the body lumen which is desired to be
imaged, and instead goes someplace else. Repositioning of the
catheter and repeated injections of contrast agent were often
previously necessary to ameliorate this problem. The present
disclosure enables displacing of a catheter to be limited or
eliminated altogether in response to fluid exit pressure such that
imaging or other intraluminal treatment or diagnostic procedures
can take place without the aforementioned problems.
[0026] In FIG. 6, a plurality of contact points, P.sub.1, P.sub.2
and P.sub.3 are shown between catheter 10 and the inner walls of
body lumen V. It is believed that stiffening catheter 10 in the
manner described herein can effectively lock catheter 10 into
position within body lumen V by way of contact with the inner walls
thereof, and thus when contrast agent is injected stiffened
catheter 10 will resist displacement. With prior art techniques,
catheter tip 18 could be expected to be at risk of slipping back,
catheter 10 straightening, and losing contact point P.sub.3 such
that contrast agent would be injected through the lower branch of
lumen V rather than the one containing treatment location/thrombus
T.
[0027] The present description is for illustrative purposes only,
and should not be construed to narrow the breadth of the present
disclosure in any way. Thus, those skilled in the art will
appreciate that various modifications might be made to the
presently disclosed embodiments without departing from the full and
fair scope and spirit of the present disclosure. For instance,
while the present description focuses on application to imaging,
alternative or supplemental treatment procedures may be
advantageously performed according to the teachings set forth
herein. Once a treatment site is imaged, various procedures may be
performed to actually treat undesired tissues or conditions of the
patient such as stent placement, thrombolysis, angioplasty, and
still others. Each of these procedures may benefit in at least
certain instances from the availability of variable stiffness in a
catheter, both as a navigational or positioning strategy to reach a
target location, and as a means for stabilizing a catheter once a
target location is reached. Thus, embodiments are contemplated in
which a catheter is stiffened prior to reading a target location,
then made more flexible, then possibly stiffened again. Variable
stiffness in a catheter is contemplated to be advantageous anywhere
a sharp curve or junction in the vascular system is to be
navigated. Exemplary but non-limiting examples include reaching the
ostium, gaining access to the carotids, and renal and pelvic
procedures. Other aspects, features and advantages will be apparent
upon an examination of the attached drawings and appended
claims.
* * * * *